MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-07-17 for ARMBOARD manufactured by Unk.
[622249]
According to the osi sales representative conversation with the hospital, the hospital had been using an older imaging top with another medical company's armboards without the suggested mizuho orthopedic systems side rail adapter. The armboards attachment clamps was also worn. The use of the device caused the carbon side rails to become damaged. The patients arm moved past the worn devices and caused the patients humerous to become broken.
Patient Sequence No: 1, Text Type: D, B5
[7969929]
Customer was requested to purchase the correct side rail adapter (5855-830) and was requested to perform regular maintenance on product before each use. The side rail adapter was purchased.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2007-00005 |
| MDR Report Key | 883670 |
| Report Source | 07 |
| Date Received | 2007-07-17 |
| Date of Report | 2007-07-17 |
| Date Mfgr Received | 2007-07-03 |
| Date Added to Maude | 2007-12-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KIRKE JAYNE |
| Manufacturer Street | 30031 AHERN AVENUE |
| Manufacturer City | UNION CITY CA 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal | 945871234 |
| Manufacturer Phone | 5104768128 |
| Manufacturer G1 | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Street | 30031 AHERN AVENUE |
| Manufacturer City | UNION CITY CA 94587123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94587 1234 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARMBOARD |
| Generic Name | ARMBOARD |
| Product Code | ILE |
| Date Received | 2007-07-17 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 920852 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-07-17 |